FDA Adverse Event
Malfunction
Summary report: N
EFFICIA DFM100
MDR report key: 18027200
·
Received October 29, 2023
Report
- Report Number
- 3030677-2023-04286
- Event Type
- Malfunction
- Date Received
- October 29, 2023
- Date of Event
- October 1, 2023
- Manufacturer
- PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.
- Product Code
- MKJ
- PMA / PMN Number
- K110825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS COMPLAINT HAS BEEN DEEMED A DUPLICATE OF PR 3911661 ALREADY REPORTED ON MDR NUMBER 3030677-2023-04222.
Description of Event or Problem · 0
IT WAS REPORTED THE DEVICE WAS NOT GETTING POWER. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE EFFICIA DFM100 DEFIBRILLATOR, MODEL# 866199, IS SUBSTANTIALLY SIMILAR TO THE HEARTSTART XL+ DEFIBRILLATOR (MODEL# 861290) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL# 861290.
Description of Event or Problem · 0
THIS COMPLAINT HAS BEEN DEEMED A DUPLICATE OF PR 3911661 ALREADY REPORTED ON MDR NUMBER 3030677-2023-04222.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 215653 | EFFICIA DFM100 | DEFIBRILLATOR | MKJ | PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. | 866199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |